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    Home > Medical News > Latest Medical News > 80% of China's clinical data are not true is the "evidence" or "examination" of Innovent's rejection

    80% of China's clinical data are not true is the "evidence" or "examination" of Innovent's rejection

    • Last Update: 2022-05-29
    • Source: Internet
    • Author: User
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    On the evening of February 10, the FDA convened the Oncology Drug Advisory Committee ODAC to discuss and vote on the review of the new drug marketing application (BLA) for sintilimab injection
    .
    In the end, with 14 votes against and 1 vote in favor, the FDA refused to approve sintilimab by requiring Innovent to supplement additional clinical trials to prove its effectiveness in American patients

    .

    Innovent’s sintilimab, as the “touchstone” of the single-country clinical data of a domestic innovative drug in the U.
    S.
    market, not only represents its own test of Innovent, but also can be considered to represent the public acceptance of Chinese innovative drugs in court.
    test to obtain an internationally recognized mark

    .

    Uncover "Black History"

    Uncover "Black History"

    Is it true that 80% of Chinese clinical data are untrue?

    Is it true that 80% of Chinese clinical data are untrue?

    However, it is worth noting that when the review committee raised several controversial points about dilimumab, the FDA directly cited the report of the Chinese drug regulatory department, saying that 80% of Chinese clinical studies were fraudulent or substandard
    .
    Once again aroused discussion in the industry, this is definitely the real situation of China's new drug clinical research?

    It is not difficult for careful readers to find that the report data cited by the FDA is the 2016 report of the China Food and Drug Administration
    .
    The source of this report needs to start from the "7.
    22" tragedy in China's pharmaceutical industry

    .
    On July 22, 2015, China's State Food and Drug Administration (CFDA) issued the strictest data verification requirements in the history of China's pharmaceutical industry, and conducted clinical data verification on 1,622 new drug applications, of which 80% of drug clinical trials failed to pass the verification

    .

    Since then, China's new drug policy reform, chemical drug registration classification reform, BE filing system, recognition of foreign clinical trial data, and simultaneous development of international new drug clinical trials have been implemented.
    Amendments to the Measures for the Administration of Drug Registration.
    .
    .

    After years of policy combination and top-level design, China's drug research and development environment has been traced back to its roots, and China's new drug research and development has basically achieved international standards
    .
    Especially since the implementation of the new drug creation project, the research and development of major varieties has achieved fruitful results

    .
    Domestic small-molecule targeted drugs such as BTK inhibitors, third-generation EGFR inhibitors, PARP inhibitors, CDK4/6 inhibitors, etc.
    have been launched one after another, as well as the current extremely introverted PD-1/PD-L1, which has broken the import of targeted drugs Monopoly over the domestic market

    .

    And the speed and data of China's drug research and development has been supported by many countries around the world
    .
    The latest and most convincing new crown vaccine researched for China has been recognized by the world, demonstrating the achievements of China's drug innovation and international standards

    .

    FDA cites "7.
    22" data

    FDA cites "7.
    22" data

    "Proof" or "Pretext"?

    "Proof" or "Pretext"?

    The ODAC's review of sintilimab, citing the data from the "7.
    22" tragedy, is strong evidence for the FDA's refusal to market sintilimab with Chinese clinical data, or is it an excuse for distrust of Chinese clinical data?

    The author believes that the FDA citing outdated data is actually unconvincing, or it is not a strong data supporting evidence that sintilimab is not approved by the FDA
    .

    Looking back on the research and development process of sintilimab, according to Yaozhi's global marketed drug screening system, Innovent Bio first applied for the clinical trial of sintilimab in January 2016, and was approved for the trial license in early September 2016
    .
    Far after the 7.
    22 clinical trial data verification, the initially declared clinical study was also not first-line non-squamous non-small cell lung cancer

    .
    The earliest application for non-squamous non-small cell lung cancer was in 2018, when Chinese drug clinical research had already returned to the right track

    .

    Data source: Yaozhi Data

    In addition, at this review meeting, the FDA actually recognized the clinical research data of sintilimab
    .
    The FDA conducted a survey of Innovent's 48 clinical centers and affirmed the professionalism of Innovent's clinical staff

    .
    The results of the ORIENT-11 clinical study of sintilimab were also affirmed, and there were no doubts about the safety and efficacy of sintilimab

    .
    The main point of contention is that the FDA believes that ORIENT-11 shows a lack of diversity in design and needs to be supplemented with studies investigating the efficacy of sintilimab in patients in the United States

    .

    In fact, since the verification of clinical data on 7.
    22, authentic, standardized and complete clinical trials have always been the key regulatory targets for new drug research and development in China

    .
    As Jorge Nieva of the University of Southern California, the only supporter of sintilimab, put it, “After sufficient FDA inspection, there is no evidence that the data provided by Innovent is unreliable, synthetic, or otherwise fraudulent

    .
    ” Thus,80 % of Chinese clinical studies are fraudulent or substandard and should not be supported data evidence

    .

    Epilogue

    Epilogue

    However, we should face up to history and take this as a lesson to learn
    from.
    Doing research in a down-to-earth manner, one step at a time, cannot let the dark history become a stumbling block on the way of our drug innovation

    .
    Although this has little impact on the direction of Chinese drug innovation to the country, it will always bring a new hint to review experts, who subconsciously believe that there are problems in Chinese drug clinical trials

    .

    At the same time, I also hope that whether it is FDA, EMA or other national drug regulatory agencies, they will not turn out the "black history" every time they review the clinical data of Chinese drugs
    .

    Look at problems from a developmental perspective
    .

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